MINI GAMMA CAMERA, MODEL MGC-500— 510(k) K040587

Name: FDA 510(k) clearance K040587
Creator: U.S. Food and Drug Administration
Published: 2004-05-14

Substantially Equivalent

Acrorad Co., Ltd.

FDA 510(k) clearance K040587 for MINI GAMMA CAMERA, MODEL MGC-500, Substantially Equivalent on 2004-05-14. Applicant: Acrorad Co., Ltd.. Device class: 1.

Clearance details

Applicant: Acrorad Co., Ltd.
Product code: Code IYX
Device class: Class 1
Regulation: 21 CFR 892.1100
Advisory panel: Radiology
Date received: 2004-03-05
Decision date: 2004-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brookeville, MD, US

Download summary PDF View on FDA.gov ↗

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